Over a Century of Medical Device Innovation

Founded in 1888, Ranfac has grown to be an established medical device manufacturing company producing specialized Class I and II single use devices. Operating out of a 40,000 square foot facility, Ranfac provides one-stop, finished good services as both an original equipment manufacturer and contract manufacturing partner. Privately owned by the Robert M. Adler Family Trust, the company is dedicated to being the most efficient partner for medical device development through continuous innovation, technology investments, and our growing and talented workforce.

Quality Policy & Design Ethos

Ranfac Corp. is devoted to maintaining the continuing effectiveness of the Quality Management System. Ranfac Corp. employees are committed to delivering products that consistently meet or exceed the requirements and reasonable expectations of our customers.

Ranfac ensures that all products are designed and manufactured with maximum quality, with the intent to be safe for both the patient and the user, in addition to being efficient for operations to build out. Quality is engrained in every step of the Design History and manufacturing process per the Ranfac quality design ethos—not just in the final step with quality control.

Regulatory Certifications

Ranfac Corp. is an ISO 13485:2016 certified medical device manufacturer. We are also certified to Directive 93/42 EEC and maintain compliance with the FDA, CGMP/QSR. Our system is designed to ensure that records are kept for trending purposes. This trending is reviewed regularly with executive management to ensure the system is staying compliant and shipping conforming products to all of our customers. Our Quality System is designed to identify and mitigate risk wherever possible. We utilize the following tools: AQL sampling and Statistical Process Control to ensure product compliance, a calibration system that ensures all of our gauges are NIST traceable and within calibration, FMEAs, Control Plans, Designs of Experiments, and IQ/OQ/PQ protocols.

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